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A prospective, multi-centre, interventional study. All subjects will use the study device for two weeks and the angulated handle available with the device must be used by each subject at least 10 times.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LoFric Elle | Experimental | New hydrophilic female urinary catheter for single use. Ready-to-Use. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LoFric Elle | Device | The study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times. |
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the subjects' Quality of Life when practicing IC using LoFric Elle catheters. | Primary objective variable is measured by the Intermittent Self-Catheterization Questionnaire (ISC-Q) total score. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance when practicing IC with LoFric Elle. | Used study catheter entire study period with the handle at least 10 times: Y/N. | 2 weeks |
| Satisfaction when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pernilla Sundqvist, MD, PhD | Örebro University Hospital, Sweden | Principal Investigator |
| Kaj Stenlöf, Dr. | Carlanderska Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alicante University General Dr. Balmis Hospital | Alicante | Spain | ||||
| Hospital Clinic Barcelona |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 17, 2024 | |
| Reset | Sep 13, 2024 | |
| Release | Sep 26, 2024 | |
| Reset | Nov 21, 2024 | |
| Release | Dec 26, 2025 | |
| Reset | Jan 15, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 17, 2024 | Sep 13, 2024 | |||
| Sep 26, 2024 |
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| 2 weeks |
| Versatility as in use of the angulated handle when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks |
| Perception when practicing IC with LoFric Elle. | PRO variables (Wellspect questionnaire). | 2 weeks |
| The catheter is perceived as slim and discreet which makes it easy to bring, store, and dispose of without obviously being a catheter. | ISC-Q domains convenience and discreetness. | 2 weeks |
| The catheter with or without the angulated handle has an ergonomic design which makes it easy to use. | ISC-Q domain ease of use. | 2 weeks |
| The catheter is perceived as ready to use. | ISC-Q question 1; it is easy to prepare my catheter for use each time I need it. | 2 weeks |
| Barcelona |
| Spain |
| Carlanderska Hospital | Gothenburg | SE-405 45 | Sweden |
| Urologiska kliniken, mottagning Universitetssjukhuset Örebro | Örebro | Örebro County | 701 85 | Sweden |
| Nov 21, 2024 |
| Dec 26, 2025 | Jan 15, 2026 |